MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number 0700001000

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2016

Event Type  malfunction  

Event Description

It was reported that after a surgical procedure at the user facility the plug of the device melted and smoked.The procedure was completed successfully using back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5484492
• MDR Text Key: 39818185
• Report Number: 0001811755-2016-00275
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0700001000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1